Progress around passage of a large coronavirus relief package this year has diminished as both parties have retreated to their respective corners, maintaining their pre-election positions on the topline figures for federal aid. President Trump didn’t provide much clarity as he urged Congress in a tweet to pass a “big and focused” relief package. The impasse on coronavirus relief does not appear to have hampered ongoing efforts to pass an omnibus spending package for fiscal year 2021 ahead of the December 11 government shutdown deadline as the Senate Majority released their bills last week and both sides have stated they want to avoid a shutdown. This all seems to be a recipe for a short-term spending bill into late February or early March, with a limited coronavirus relief package attached.
In the meantime, the House is scheduled to vote on a series of relatively uncontroversial health-related bills relating to public health, health disparities, regulation of generic drugs and orphan drugs, curbing the opioid crisis, and veteran health (described below), though Senate action on these measures is unclear. The Trump administration is expected to proceed with policymaking through regulations, as several highly anticipated rules await review at the Office of Management and Budget (OMB).
Negotiation on an attempt to get a longer-term coronavirus relief package is still likely as House Speaker Nancy Pelosi (D-CA) and Senate Democratic Leader Chuck Schumer (D-NY) are pushing for the $2.4 trillion Heroes Act as “the starting point” for negotiations, contending that the record-breaking COVID-19 infections and hospitalizations and high unemployment numbers warrant the multi-trillion dollar response. The U.S. has recorded more than 100,000 new coronavirus cases for 12 days in a row and nearly 70,000 current hospitalizations, according to the COVID Tracking Project.
Senate Majority Leader Mitch McConnell (R-KY) points to the increase of 638,000 jobs in October and 1.0 percentage point drop in the unemployment rate to 6.9 percent as indicators that a more modest stimulus package costing $500 billion is sufficient. Still, the possibility that Democrats may flip the Senate in January, though slim, may motivate Republicans to try to strike a deal this year while they still have an ally in the White House. Democrats would like to clear the decks for the incoming Biden Administration with a larger package.
President Trump is expected to finalize a slate of new rules in the coming weeks. Currently at the Office of Management and Budget (OMB) for review are the final rules for the CY 2021 Medicare Physician Fee Schedule and the Hospital Outpatient Prospective Payment System. Also under review is the final rule that would allow pharmaceutical manufacturer discounts to be passed through directly to patients at the point of sale – a previously abandoned regulatory initiative that President Trump recently revived through Executive Order.
In addition, two rules which have cleared OMB review may be published in the Federal Register as early as this week – a proposed rule that would modify existing HIPAA rules that act as barriers to coordinated care and a final rule that would modify 42 CFR Part 2 confidentiality requirements for substance use disorder patient records.
It is also possible that the Trump administration will soon release next steps on its long-anticipated Most Favored Nations (MFN) demonstration model – an outgrowth of the International Pricing Index (IPI) model for Medicare Part B the administration originally previewed in 2018. The precise nature of these next steps is presently unclear, though some are anticipating the release of an interim final rule to effectuate the MFN provisions that would implicate Part B. Any potential feature of the MFN model that would extend to Part D may come in the form of a proposed rule – a customary approach that the Centers for Medicare and Medicaid Services (CMS) has taken when considering mandatory demonstration models, though one which is not formally required by statute.
This week, the Senate is scheduled to consider several judicial and executive nominees. As for the House, votes are scheduled for the following bills. While the measures are expected to pass, it remains to be seen whether the Senate will take up the House bills this session.
- Securing America From Epidemics Act (R. 6334) would authorize the United States to participate in the Coalition for Epidemic Preparedness Innovations (CEPI), an alliance of countries and private partners whose mission is to finance and coordinate the development of vaccines for high-priority, epidemic-potential threats.
- FASTER Act of 2020 (R. 2117) would (1) require Centers for Disease Control and Prevention (CDC) to expand and intensify collection of food allergy data; (2) require food labels to include sesame as a major allergen; (3) allow the Food and Drug Administration (FDA), through regulation, to add other food ingredients as major allergens based on the prevalence and severity of allergic reactions; and (4) require the FDA to include patient experience data on treatment for patients with food allergies in its report on patient experience data. There is no related bill in the Senate.
- Bipartisan Solution to Cyclical Violence Act of 2020 (R. 5855) would create a grant program at the Department of Health and Human Services (HHS) to support trauma centers with violence intervention and violence prevention programs. Program support would be provided to conduct research to reduce the incidence of re-injury and re-incarceration caused by intentional violent trauma, including intimate partner violence. There is no related bill in the Senate.
- NIMHD Research Endowment Revitalization Act of 2020 (R. 4499) would authorize the National Institute on Minority Health and Health Disparities to facilitate research on minority health disparities through research endowments at current or former centers of excellence. The Senate passed an identical bill (S. 2927) by voice vote in May 2020.
FDA Regulation of Drugs
- MODERN Labeling Act of 2020 (R. 5668) would authorize the FDA to require modifications of outdated labeling for generic drugs. Identical language is included in the Lower Health Care Costs Act (S. 1895), the bipartisan health care package championed by Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA).
- Fairness in Orphan Drug Exclusivity Act (R. 4712) would update the Orphan Drug Act to require manufacturers seeking orphan status for any drug to show they have no reasonable expectation of recovering research and development costs through sales in the U.S. for the entirety of the seven-year exclusivity period. A related bill (S. 3271) with minor differences in the Senate has bipartisan support.
- State Opioid Response Grant Authorization Act of 2020 (R. 2466) would authorize the Substance Abuse and Mental Health Services Administration (SAMHSA) State Opioid Response Grants program through FY 2026. There is no related bill in the Senate.
- Easy MAT for Opioid Addiction Act (R. 2281) would require the Drug Enforcement Agency (DEA) to revise regulations to allow a practitioner to administer up to a three-day supply of medication-assisted treatment (MAT). Current regulations allow up to a one-day supply of MAT, for a total of up to three days. There is no related bill in the Senate.
- Block, Report, And Suspend Shipments Act of 2020 (R. 3878) would create additional requirements for drug manufacturers and distributors who discover a suspicious order for controlled substances. In addition to reporting the suspicious order to DEA, the bill would require a manufacturer or distributor to exercise due diligence, decline to fill the order or series of orders, notify DEA of each suspicious order or series of orders and the indicators that led to the belief that filling such orders would be a violation. There is no related bill in the Senate.
- DEBAR Act of 2020 (R. 4806) would amend the Controlled Substances Act to allow the Attorney General to prohibit any registrant from manufacturing, distributing, or dispensing a controlled substance or a list I chemical if that registrant meets or has met any of the conditions for suspension or revocation of registration under subsection (a) of the Act, or is found unfit to manufacture, distribute, or dispense a controlled substance or a list I chemical. There is no related bill in the Senate.
- Ensuring Compliance Against Drug Diversion Act of 2019 (R. 4812) would terminate the controlled substance registration of any registrant if the registrant dies, ceases legal existence, discontinues business or professional practice, or surrenders registration. There is no related bill in the Senate.
- FENTANYL Results Act (R. 7990) would authorize two programs through the State Department aimed at building foreign law enforcement capacity and increasing global cooperation to curb synthetic drug trafficking. A companion bill in the Senate (S. 4514) has bipartisan support.
- Improving Safety and Security for Veterans Act of 2019 ( 3147) would require the Department of Veterans Affairs (VA) to report on p
- atient safety and quality of care and the steps the VA has taken to improve care at VA medical centers. The Senate passed the bill by unanimous consent in December 2019.